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Health Canada News

Health Canada’s Latest Front-of-Package Labelling Updates

Post author By Quality Smart Solutions
Post date March 13, 2025

Introduction

Health Canada FOP labelling updates can impact your business, especially if you sell prepackaged foods. Recently, Health Canada announced interim policies affecting fresh coconut products and certain ready-to-eat breakfast cereals. Understanding these changes will help you stay compliant and avoid unnecessary disruptions to your business.

In this blog, we’ll break down exactly what these Health Canada updates mean for you, how to ensure compliance with front-of-package (FOP) nutrition labelling requirements, and what flexibility has been introduced. Keep reading to simplify your regulatory process.

Health Canada’s new interim policies: what changed?

On March 12, 2025, Health Canada announced two significant interim policies regarding front-of-package nutrition labelling:

Exemption for prepackaged fresh coconut: Prepackaged fresh coconut products are exempt from displaying the FOP nutrition symbol.
Flexibility for dense breakfast cereals: Specific dense, ready-to-eat breakfast cereals have been granted flexibility concerning FOP nutrition symbol assessments.

These interim decisions aim to streamline packaging requirements while addressing practical concerns from industry stakeholders.

Understanding the fresh coconut labelling exemption

If you sell prepackaged fresh coconut products, the new Health Canada interim policy exempts you from mandatory FOP nutrition labelling. Previously, complying with these labelling requirements presented challenges for products like fresh coconut, which naturally contain saturated fats that would otherwise trigger the FOP symbol.

This exemption helps reduce packaging complexity and saves your business valuable time and resources, letting you focus on product quality and customer satisfaction.

New flexibility for dense breakfast cereals

For manufacturers of dense, ready-to-eat breakfast cereals, Health Canada’s interim policy provides valuable flexibility. These cereals, often high in nutritional value but also dense in certain nutrients triggering mandatory labelling, now have revised guidelines for assessing the need for FOP symbols.

This flexibility recognizes the unique nutritional profiles of such products, potentially reducing labelling burdens and simplifying your product’s market entry or adjustments.

How to ensure compliance

To benefit from these policy updates:

Review your product categories to determine applicability.
Verify the nutrient density and packaging details of your products against updated guidelines.
Ensure clear documentation to support your exemption or flexibility under these interim measures.

Properly understanding and implementing these policies can help you maintain compliance, boost consumer trust, and position your brand as an informed and responsible player in the Canadian market.

Stay ahead with regulatory changes

Navigating evolving regulatory landscapes doesn’t have to be complicated. At Quality Smart Solutions, we specialize in helping brands like yours adapt swiftly to Health Canada regulations.

If you have questions about FOP labelling compliance or how these updates specifically impact your products, our regulatory experts are here to help.

Ready to simplify your regulatory journey? Contact us today or fill out the form below and let our experts guide you through Health Canada’s latest policies.

Tags food industry, Health Canada, Nutrition Labelling

Cannabis News

Health Canada Reviews CBD as an NHP in New Consultation

Post author By Quality Smart Solutions
Post date March 7, 2025

Health Canada Reviews CBD as an NHP

Health Canada is conducting a public consultation on CBD regulations for natural health products, exploring a pathway to allow non-prescription CBD products under the Natural Health Products Regulations (NHPR). This consultation opened on March 7, 2025, and will close on June 5, 2025.

The proposed framework aims to expand access to non-prescription CBD products while maintaining strict safety, efficacy, and quality standards. If adopted, these changes could reshape CBD compliance and licensing requirements for businesses across Canada.

Key changes under review

The consultation focuses on several regulatory updates that would impact CBD regulations for natural health products, including:

CBD as an NHP ingredient – Amending the Natural Health Products Regulations to allow CBD for treating minor ailments.
Veterinary CBD products – Regulating non-prescription veterinary drugs under the Food and Drug Regulations for animal health.
Product classification – Determining if CBD should remain prescription-only or be available as an NHP based on scientific evidence.
Harmonization with the Cannabis Act – Ensuring regulatory consistency between the Food and Drugs Act and the Cannabis Act for CBD products.
Reducing licensing burdens – Considering whether cannabis drug and research licensing requirements should be removed for businesses handling only CBD.

These changes could allow CBD health products to be regulated like other non-prescription medicinal ingredients, making them more accessible while maintaining strict safety and efficacy standards.

Why this matters for businesses

These regulatory changes could significantly impact CBD product manufacturers, retailers, and distributors. If CBD is included in the NHP framework, companies may be able to introduce non-prescription CBD health products in compliance with Health Canada’s standards. However, businesses must ensure their products meet NHP safety, efficacy, and quality requirements.

New guidelines may also introduce labeling and marketing restrictions, limiting product claims, ingredient disclosures, and advertising. Additionally, Canada’s international treaty obligations could influence CBD import and export policies, affecting businesses with global operations.

Who should participate in the consultation?

Health Canada is seeking feedback from:

CBD manufacturers and retailers
Healthcare professionals, including veterinarians
Researchers and academic institutions
Indigenous organizations
Animal welfare groups
Consumer advocacy organizations
Members of the public

Businesses involved in CBD product development should take this opportunity to provide input on how Health Canada shapes future regulations.

How to submit feedback

This public consultation is open from March 7, 2025, to June 5, 2025. Stakeholders can submit their input by reviewing the discussion paper and responding to Health Canada’s consultation questions.

Review the Discussion Paper – Read Towards a Pathway for Health Products Containing Cannabidiol for details on the proposed regulatory framework.
Consider the discussion questions – Health Canada has outlined key topics such as CBD classification, NHP safety standards, and compliance requirements.
Submit feedback before June 5, 2025 – Businesses and stakeholders can share comments through the online feedback form or email nnhpd.consultation-dpsnso@hc-sc.gc.ca.

All submissions will be reviewed as part of Health Canada’s policy development process.

What businesses should do next

With CBD regulations for natural health products under review, businesses should take proactive steps to prepare for potential changes. Key actions include reviewing product formulations, adjusting licensing and labeling, and monitoring regulatory updates,

Navigating CBD regulatory changes can be complex. At Quality Smart Solutions, we provide compliance consulting, product registration services, and regulatory audits to help businesses meet Health Canada’s evolving CBD requirements.

For expert guidance, fill out the form below or contact us.

Tags CBD regulations, Health Canada compliance, Nhp

Health Canada News

Health Canada to Prioritize Canadian-Made Class III NHPs

Post author By Quality Smart Solutions
Post date March 4, 2025

The Natural and Non-prescription Health Products Directorate (NNHPD) has changed the review process for Class III Natural Health Product (NHP) applications. Due to a growing backlog and higher submission volume, Health Canada will now prioritize applications for products sold or manufactured in Canada within six months of licensing.

Starting March 5, 2025, NNHPD will no longer review Class III applications based only on their submission date. Instead, priority will go to products that support the Canadian market. If you plan to bring an NHP to Canada, now is the time to act. Learn how these changes affect your application and how to stay ahead.

Why is this changing?

In recent years, NNHPD has received a surge in Class III NHP applications. These applications require the most resources and time to review. The high volume has exceeded the directorate’s capacity, causing delays in meeting the 210-day service standard.

Previously, applications were reviewed on a first-come, first-served basis. However, Health Canada found that some submissions were for products not intended for sale or manufacturing in Canada. These applications slowed down the process. The new system prioritizes applications that benefit Canadian businesses and consumers, improving efficiency.

Which applications get priority?

Health Canada will prioritize Class III NHP applications that meet at least one of these criteria:

New applications for products sold in Canada within six months of licensing.
Amendments to authorized NHPs intended for the Canadian market within six months of revision.
Applications or amendments for products manufactured in Canada within six months of licensing.

To qualify for prioritization, applicants must submit a Workload Management Form. Applications without this form will be deprioritized and reviewed based on resource availability.

What does this mean for businesses?

These changes will impact approval timelines and require a new approach for businesses introducing NHPs in Canada. Here’s what you should do:

Check your product plans – Ensure your application meets the new prioritization criteria before submitting.
Submit the Workload Management Form – Without it, your application will be reviewed later, when resources allow.
Plan ahead – If your product won’t be sold or manufactured in Canada within six months, expect longer wait times.
Stay updated – Follow Health Canada’s official bulletin for ongoing updates.

What should you do next?

Keeping up with Health Canada’s changing regulatory landscape requires careful attention to new requirements and evolving priorities. Quality Smart Solutions offers expert guidance on NHP licensing, regulatory compliance, and submission strategies to help businesses streamline their applications.

If you need help managing your NHP regulatory submissions, contact us today or fill out the form below to ensure your product reaches the Canadian market efficiently.

By staying proactive and adapting to these regulatory changes, businesses can avoid unnecessary delays and successfully navigate Health Canada’s workload management system for Class III NHP applications.

Tags Health Canada, Natural Health Products, Nhp

Health Canada News

Canada Updates Supplemental Ingredients Compliance Rules

Post author By Quality Smart Solutions
Post date March 3, 2025

Are Your Supplemental Ingredients Compliant? Canada’s New Rules Explained

If your business sells supplemented foods in Canada, major regulatory updates are on the horizon. Health Canada has introduced new compliance rules for supplemental ingredients declared on product labels, with full enforcement set for December 31, 2025.

These updates impact how your products are labelled and tested, and failing to comply could mean product recalls, fines, or even removal from the market.

Understanding and implementing these changes is crucial to keeping your products on store shelves and maintaining consumer trust. But what do these new rules mean for your business? How can you ensure compliance without disrupting operations?

Keep reading to learn exactly what’s changing, how it affects you, and the steps you need to take now to stay ahead.

What’s Changing? New Compliance Rules for Supplemented Foods

In July 2022, Health Canada introduced the Supplemented Foods Regulations, a risk-based framework that governs how supplemented foods must be labelled and tested. These products must now use a Supplemented Food Facts table instead of a traditional Nutrition Facts table, ensuring transparency and consistency in labelling.

The goal of these updates is to prevent misleading claims and establish clearer compliance requirements for supplemental ingredients. As a business owner, you need to be aware of how these changes impact ingredient testing, rounding rules, and compliance limits.

Key Compliance Factors You Need to Know

1. New Testing Requirements for Supplemental Ingredients

The declared amount of a supplemental ingredient on a label must match lab-tested results within strict compliance limits.

Some ingredients must meet minimum required levels, while others can have a slight variation below the declared value.

2. Rounding Rules Impact Labelling Compliance

Health Canada enforces specific rounding rules for supplemented food labels.

The percentage daily value for vitamins and minerals must be calculated using rounded figures to align with regulatory standards.

3. Compliance Limits for Supplemental Ingredients

Health Canada applies different compliance limits based on ingredient type:

Minimum compliance limits apply to vitamins, minerals, and amino acids. These ingredients must be at least 50% of the declared value after rounding.

Maximum compliance limits apply to certain supplemental ingredients like caffeine, which cannot exceed 150% of the declared value to protect consumer safety.

4. Overages and Flexibility for Manufacturers

Previously, Health Canada proposed a strict 150% overage limit, but after industry feedback, this restriction was removed.

Manufacturers can now use Good Manufacturing Practices (GMPs) to determine acceptable overages based on processing needs.

Why Compliance Matters for Your Business

Failing to meet these new regulations could lead to product recalls, fines, and market restrictions. Compliance ensures your products remain eligible for sale in Canada and meet consumer expectations for transparency and safety.

At Quality Smart Solutions, we help businesses navigate Health Canada’s regulatory landscape with ease. Whether you need guidance on labelling, compliance assessments, or regulatory consulting, our experts are here to support you.

Fill out the form below or contact us to schedule a consultation with one of our regulatory specialists.

Tags food industry, Health Canada, Regulatory Compliance

Food Safety News

New Organic Product Import Rules Coming to Canada

Post author By Quality Smart Solutions
Post date February 6, 2025

The Canadian Food Inspection Agency (CFIA) is introducing new measures to strengthen import controls for organic product import compliance. These controls are being enhanced to ensure the integrity of organic claims, prevent misleading labeling, and align with international certification standards.

As part of a two-phase project, Phase 1 was successfully implemented in November 2024, and Phase 2 is set to take effect on May 26, 2025.

Does your business import organic foods into Canada? If so, you must prepare for these changes to avoid supply chain disruptions. Keep reading to learn more and stay compliant.

What’s Changing?

The second phase of CFIA’s import control project requires importers and brokers to submit a digital copy of their organic certificate as part of the Integrated Import Declaration (IID), commonly referred to as the CBSA Single Window system. All organic imports must include either an uploaded certificate or a Unique Reference Number (URN), which links to a previously submitted certificate to streamline compliance.

Key Updates Effective May 26, 2025

Importers and brokers must upload a digital copy of the organic certificate during the IID submission.
The Canada Border Services Agency (CBSA) will issue a URN for each uploaded certificate, which can be reused for multiple shipments.

Import declarations can contain multiple URNs where applicable.

Failure to include a digital certificate or URN will result in a rejected import declaration until compliance is met.

How This Affects Importers and Brokers

If your business is involved in organic product import, these regulatory changes will directly impact your import process. Here’s what you need to do to remain compliant:

Ensure You Have a Digital Copy of Your Organic Certificate – This document must be readily available and uploaded at the time of import declaration.
Familiarize Yourself with AIRS Updates – CFIA’s Automated Import Reference System (AIRS) now includes newly added organic products. Importers must stay up to date with these additions.
Use the URN System Efficiently – If you have already provided an organic certificate for a shipment, use the assigned URN for future declarations to streamline the process.
Avoid Delays and Rejections – Missing documentation will result in import declaration rejections, which can disrupt business operations and lead to delays in product distribution.

Stay Compliant with Quality Smart Solutions

Navigating new organic product import regulations can be complex, but Quality Smart Solutions is here to help. Our experts provide guidance on regulatory compliance, helping businesses meet CFIA and CBSA requirements seamlessly. Ensure your business stays ahead of compliance changes. Contact us today or fill out the form below to learn how we can support your import processes.

For further details, refer to the official CFIA announcement or contact the Canada Organic Regime team at OPR-RPB@inspection.gc.ca.

Tags Canada Organic Regime, Regulatory Updates

Blog GRAS

GRAS in Pet Food: A Guide to Ingredient Compliance

Post author By Quality Smart Solutions
Post date February 5, 2025

GRAS in pet food – these four words can make a big difference in your product’s regulatory status. Understanding what GRAS designation means and how it impacts your pet food formulations is essential for navigating the complex world of animal feed regulations. This guide will break down the key aspects of Generally Recognized as Safe (GRAS) status, helping you ensure your pet food products meet the required standards.

Navigating the regulatory landscape of pet food ingredients can be challenging. Therefore, staying informed about GRAS in pet food and its implications is crucial for pet food manufacturers, distributors, and anyone involved in the animal feed industry. Read on to learn more about this critical aspect of pet food compliance.

What is GRAS?

GRAS stands for Generally Recognized as Safe. In the context of pet food, it signifies that a specific ingredient is considered safe for its intended use in animal feed, based on scientific evidence or a history of safe use in food. The FDA’s Center for Veterinary Medicine (CVM) oversees the GRAS notification program for animal food. Essentially, GRAS status offers a pathway for companies to affirm the safety of their ingredients without undergoing the formal food additive approval process. You can find more information on the FDA’s GRAS Notification Program website.

How Does GRAS Determination Work?

There are two primary ways to establish GRAS status for a pet food ingredient:

Scientific Procedure: This involves conducting robust scientific studies that demonstrate the safety of the ingredient for its intended use in animal feed. These studies typically include toxicology tests, feeding trials, and other relevant research. This data is then evaluated by qualified experts.
History of Safe Use: If an ingredient has a long history of safe use in food (for humans or animals), it may be considered GRAS based on that history. This requires demonstrating a substantial history of safe consumption.

Why is GRAS Important for Pet Food?

GRAS designation plays a crucial role in ensuring the safety and quality of pet food products. It provides a framework for evaluating the safety of ingredients, protecting animal health, and building consumer trust. Moreover, it helps streamline the regulatory process for new ingredients, fostering innovation in the pet food industry. Properly establishing GRAS in pet food status is essential for avoiding regulatory issues and ensuring your products are compliant.

GRAS Notification Process

While not mandatory, many companies choose to submit a GRAS notification to the FDA for their ingredients. This process involves providing detailed information about the ingredient, its intended use, and the scientific basis for its safety.

The FDA then evaluates the notification and issues a letter stating whether it has any questions about the notifier’s GRAS conclusion. This process adds a layer of transparency and strengthens the credibility of the GRAS determination.

Key Considerations for GRAS in Pet Food

Intended Use: The specific purpose of the ingredient in the pet food formulation is a critical factor in GRAS evaluation.
Animal Species: GRAS status can vary depending on the target animal species (e.g., dogs, cats, birds).
Concentration: The level of the ingredient in the final pet food product is another important consideration.
Data and Documentation: Thorough documentation of the scientific evidence or history of safe use is essential for supporting a GRAS determination.

Staying Compliant with GRAS Regulations

Navigating the complexities of GRAS in pet food regulations can be challenging. Therefore, partnering with experts in regulatory affairs and food safety can be invaluable. Quality Smart Solutions can help you navigate the GRAS notification process, ensuring your pet food products meet all necessary requirements. Contact us today to learn more about how we can support your GRAS compliance efforts.

Tags Food Safety, GRAS, ingredient compliance, pet food

Blog Food Safety

How Bill 96 Impacts Bilingual Labelling in Canada

Post author By Quality Smart Solutions
Post date January 29, 2025

The introduction of Bill 96 in Quebec brings new challenges for businesses across Canada. As a result, this legislation emphasizes the importance of the French language and enforces stricter rules for bilingual labelling.

If your products reach the Quebec market, you must understand these regulations to maintain compliance and avoid penalties. Keep reading to learn how Bill 96 affects your business and what steps you can take to stay compliant.

What Is Bill 96?

Bill 96, formally known as “An Act respecting French, the official and common language of Québec,” strengthens Quebec’s Charter of the French Language. In other words, the law aims to protect and promote French as the predominant language in the province. More specifically, one of its key areas of impact is on bilingual product labelling, which is now subject to stricter enforcement and additional requirements.

Key Changes to Bilingual Labelling

1. Mandatory French Language Dominance

Under Bill 96, French must not be given lesser prominence than other languages on product labels and packaging. This means:

French text must be displayed before any other language.
Font size for French text must be equal to or larger than the font size of other languages.

2. Changes to Trademarks

Bill 96 restricts the use of non-French trademarks on product packaging. Previously, businesses could use any recognized trademark in English or another language without a French translation. Now, only registered trademarks (or those with pending applications) can remain in English. If a trademark is unregistered, it must be translated into French.

Additionally, if a registered trademark contains generic or descriptive terms, those words must appear in French somewhere on the packaging.

3. Expanded Scope of Products

In addition to retail packaging, the regulation extends to include instruction manuals, warranty cards, and promotional inserts.

4. New Compliance Deadlines

Businesses must comply with the new regulations by June 1, 2025. Non-compliant products manufactured before this date have a two-year phase-out period, allowing them to remain on the market until June 1, 2027. Companies should ensure all labelling updates are completed on time to avoid non-compliance penalties.

Who Is Affected by Bill 96?

As a consequence of these changes, several groups must adhere to the new rules:

Businesses operating in Quebec: Companies distributing products in Quebec must adhere to the new rules, regardless of whether they are based inside or outside the province.
International manufacturers: Similarly, businesses exporting goods to Quebec must comply with these bilingual labelling regulations to sell products in the market.
Retailers: Any retailer distributing non-compliant products may face fines or be required to pull products off shelves.

What Are the Risks of Non-Compliance?

Failing to comply with Bill 96 can result in serious consequences. For example:

Fines and penalties: Businesses can face significant financial consequences for violations.
Product recalls: Non-compliant items may need to be removed from Quebec markets, disrupting supply chains.
Reputational damage: Failure to adhere to regulations may harm your brand’s credibility in a sensitive consumer market.

How to Ensure Compliance with Bill 96

To stay compliant, consider these proactive steps:

Audit Your Labels: Review all product packaging to ensure French text is prominently displayed and meets font size requirements.
Update Marketing Materials: Likewise, ensure that any promotional materials, including digital content and brochures, comply with the new rules.
Engage with Compliance Experts: For a smoother process, partnering with regulatory professionals, like Quality Smart Solutions, can streamline the compliance process. Our team helps businesses navigate complex regulations and implement practical solutions.
Educate Your Team: Train your staff on the implications of Bill 96 to ensure company-wide adherence to the regulations.

Why Partner with Quality Smart Solutions?

Navigating the regulatory landscape can be overwhelming. That’s why at Quality Smart Solutions, we specialize in guiding businesses like yours through compliance challenges. Whether it’s bilingual labelling or broader regulatory strategies, we’re here to help.

Don’t wait until it’s too late. Let us support your business in staying ahead of the curve. Contact us today for a consultation.

Tags bilingual labelling, Bill 96, Regulatory Compliance

News

What’s New in the EFSA QPS Update for Food Safety?

Post author By Quality Smart Solutions
Post date January 22, 2025

The EFSA QPS update is here, and it brings important changes for businesses involved in food and feed safety. As the European Food Safety Authority (EFSA) continuously evaluates microorganisms intentionally added to food and feed, this new update reflects the most recent findings and safety considerations.

Whether you’re a producer, importer, or distributor in the food and feed industries, staying informed about the QPS list changes is crucial for ensuring compliance and maintaining safety standards.

Let’s dive into what this update means for your business and how it might affect your operations.

What Is the Qualified Presumption of Safety (QPS)?

The Qualified Presumption of Safety (QPS) is a process developed by EFSA to evaluate microorganisms intentionally added to food and feed. By identifying taxonomic units (TUs) that are generally considered safe, EFSA helps businesses streamline safety assessments, reducing the need for exhaustive individual evaluations. This list is updated regularly based on new research.

EFSA introduced the QPS approach in 2004, following a Scientific Opinion that built on a 2003 working document titled “On a generic approach to the safety assessment of microorganisms used in feed/food and feed/food production.”

This document was developed by a specialized working group, including experts from the Scientific Committee on Animal Nutrition, the Scientific Committee on Food, and the Scientific Committee on Plants of the European Commission. Establishing QPS status is based on four key criteria:

Taxonomic identification – The microorganism must be classified under a clearly defined taxonomic unit (TU).
Body of knowledge – Sufficient scientific data must be available to assess human and animal exposure through food and feed.
Safety concerns – The microorganism must not contain known safety risks.
Intended use – The assessment considers how the microorganism will be used in food or feed production.

By following these strict scientific principles, EFSA ensures a transparent, consistent, and efficient evaluation process for microorganisms in the food and feed industry.

Key Changes in the EFSA 2025 QPS Update

The 2025 update introduces several important changes that could impact your business:

1. New Microorganisms Assessed for QPS Status

In the latest update, Lacticaseibacillus huelsenbergensis has been granted QPS status, owing to its close relation to other safe Lacticaseibacillus species. This is good news for businesses using Lacticaseibacillus strains in their products.

2. Exclusions and Safety Concerns

EFSA also identified microorganisms that pose safety risks. For example, Bacillus thuringiensis was excluded from the QPS list due to its potential to produce harmful toxins. Businesses working with Bacillus species should ensure that their products meet safety standards.

3. Verification of Previously Approved Microorganisms

The update also verifies the safety of microorganisms that are already on the QPS list. Most previously approved taxonomic units remain on the list, offering stability for businesses using these microorganisms.

How This Affects Your Business

For businesses in the food and feed sectors, the EFSA QPS update provides a clear framework for ensuring that your products are safe for consumers. By using microorganisms approved for QPS status, you meet regulatory requirements and ensure safety.

If you’re involved in product development, the QPS list can guide ingredient selection. With Lacticaseibacillus huelsenbergensis now on the list, you may consider it for use in your products.

The update also helps you manage risks. For instance, the exclusion of Bacillus thuringiensis due to safety concerns means you need to avoid using strains that could compromise product safety.

Next Steps for Your Business

To stay compliant with EFSA’s regulations, you can:

Review the QPS list: Check whether the microorganisms used in your products are on the latest QPS list.
Collaborate with suppliers: Ensure your suppliers are aware of the new updates and use compliant ingredients.
Consult experts: If you need clarification on the QPS status of specific microorganisms, reach out to regulatory experts for guidance.

The EFSA 2025 QPS update is a vital development for ensuring food and feed safety across Europe. By staying informed about the changes and aligning your processes with the updated list, you can maintain compliance, mitigate risks, and foster innovation in your business.

If you need to get expert advice, contact us at Quality Smart Solutions. For more information on the latest updates, read EFSA’s article.

Tags EFSA, Food Safety, Microorganisms, QPS, Regulatory Updates

News

FDA to Revoke Use of Red No. 3: What You Need to Know

Post author By Quality Smart Solutions
Post date January 17, 2025

The FDA has just announced a significant decision: Red No. 3, a widely used synthetic dye in foods and ingested drugs, is being banned. This move has sparked attention across industries due to its potential impact on production and compliance requirements. If you’re wondering how this decision affects you and what steps you need to take, you’re in the right place. Let’s explore the details together so you can stay informed and prepared.

In this article, we’ll break down the FDA’s ruling, explain what it means for businesses and consumers, and provide actionable guidance to ensure you remain compliant.

Why Is the FDA Banning Red No. 3?

Red No. 3 has been a common ingredient in many colorful foods and pharmaceutical products. However, scientific studies have linked the dye to potential carcinogenic risks in laboratory animals. Public health advocates have long campaigned for its removal, emphasizing the need for safer alternatives.

The FDA’s decision to ban Red No. 3 highlights its commitment to consumer safety and aligns with international regulatory trends to eliminate harmful additives from products.

What Does This Mean for Manufacturers?

The FDA’s ban on Red No. 3 prohibits its use in food products, including candies, baked goods, and beverages, as well as ingested drugs, such as over-the-counter medications. To comply, manufacturers must:

Reformulate products using FDA-approved color additives.
Update product labels to reflect the absence of Red No. 3.
Revise compliance strategies to avoid regulatory issues.

Steps to Ensure Compliance

Here are some actionable steps businesses can take:

Audit product lines:

Identify all products containing Red No. 3 and prioritize reformulation for high-volume or fast-moving items.

Partner with suppliers:

Collaborate with ingredient suppliers to secure safe, FDA-approved alternatives. Maintain quality assurance protocols throughout the supply chain.

Update labels and packaging:

Ensure product labels comply with updated FDA regulations by removing Red No. 3 from ingredient lists. Highlight new formulations where applicable.

Monitor regulatory updates:

Stay informed on FDA guidelines and industry trends. Join relevant associations or subscribe to compliance-focused resources for real-time updates.

Consumer Impact and Industry Trends

Consumers are increasingly demanding transparency and safety in food and drug products. The FDA’s ban on Red No. 3 may accelerate the shift toward natural, plant-based colorants. Businesses that adapt quickly can position themselves as leaders in offering clean and safe products, earning trust and loyalty from health-conscious consumers.

Need Support with FDA Compliance?

Quality Smart Solutions offers expertise in navigating complex regulatory requirements. From product audits to reformulation strategies, our team ensures your operations meet FDA standards.

Staying informed and proactive is essential as the FDA enforces the ban on Red No. 3. Businesses that prioritize compliance and consumer safety can turn this regulatory change into a valuable opportunity.

Tags FDA compliance

News

What’s Behind the FDA’s New Front-of-Package Labeling Proposal?

Post author By Quality Smart Solutions
Post date January 16, 2025

The FDA’s proposed front-of-package (FOP) nutrition labeling rule introduces significant changes to how nutritional information is displayed. This proposal reflects growing efforts to address public health concerns, such as obesity and chronic diseases, by encouraging informed food choices.

For your business, this new nutrition labeling proposal is an opportunity to enhance transparency, build consumer trust, and showcase a commitment to public health. At the same time, it presents challenges that require preparation and strategic planning.

Curious about how these changes might impact your operations or how they compare to Canada’s regulations? Read on to uncover the key takeaways and strategies for staying ahead.

Key Takeaways from the FDA’s Proposed FOP Regulations

The FDA’s nutrition labeling proposal marks a significant step toward improving transparency in food labeling and empowering consumers with better information. Here’s what you need to know:

Uniform labeling standards: A consistent design will be required to improve readability and comparability across products.
Nutritional focus: The rule prioritizes calories, added sugars, saturated fat, and sodium as key data points on packaging.
Broad application: The changes will affect nearly all packaged foods and beverages sold in the U.S., with few exceptions, such as single-ingredient foods, small package sizes, medical foods, infant formula, alcoholic beverages, and dietary supplements.

These measures align with the goals of the nutrition labeling proposal to address health concerns like obesity and chronic diseases by promoting informed dietary choices.

How Does This Compare to Canada’s FOP Regulations?

Canada’s front-of-package labeling regulations, introduced in 2022, offer a useful benchmark for understanding the FDA’s approach. Key comparisons include:

Symbols vs. text: Canadian labels employ visual symbols to denote high nutrient levels, while the FDA’s proposal focuses on text-based presentation.
Compliance timelines: Canada set a clear transition period for FOP labeling regulations, allowing voluntary compliance from July 20, 2022, to January 1, 2026. After this date, all applicable products must display the FOP nutrition symbol. The FDA’s timeline is still pending finalization, but once the rule is published, large businesses ($10M+ in annual food sales) will have three years to comply, while small businesses (under $10M) will have four years.

These distinctions are critical for businesses operating in both markets, as they may require tailored strategies to ensure compliance.

Why This Matters for Your Business

Adapting to these updates is essential for maintaining compliance and building trust with your consumers. Here’s why it’s important:

Consumer trust: Transparent labels increase consumer confidence and can boost brand loyalty.
Regulatory compliance: Meeting FDA requirements avoids the risks of fines, recalls, or other penalties.
Market leadership: Proactive adoption of FOP labels can set your brand apart as a forward-thinking industry leader.

Steps to Prepare for FDA’s FOP Regulations

Taking a proactive approach to the nutrition labeling proposal ensures your business remains compliant, competitive, and aligned with evolving consumer expectations. Consider these steps:

Evaluate existing labels: Conduct a thorough review of your current packaging to identify areas needing updates.
Engage with experts: Work with regulatory compliance specialists like Quality Smart Solutions for guidance and support.
Stay informed: Monitor FDA announcements for updates on implementation timelines and final rules.
Train your teams: Educate your internal teams to ensure alignment with the new requirements.

Partner with Quality Smart Solutions

At Quality Smart Solutions, we specialize in helping businesses navigate complex regulatory landscapes. Whether it’s label audits, compliance strategies, or market insights, we’re here to ensure your products meet the latest standards. Let us guide you through the FDA’s proposed front-of-package nutrition labeling updates. Contact us.

Final Thoughts

The FDA’s proposed front-of-package nutrition labeling rule is a significant step toward empowering consumers and enhancing transparency in food labeling. Comparing it to Canada’s established regulations highlights the growing global emphasis on informed choices.

Preparing your business now ensures compliance, fosters consumer trust, and positions your brand as a leader in the evolving food industry landscape. Take action today to prepare for these changes and keep your business ahead of the curve!

Tags FDA compliance, food industry updates, nutrition labeling

Events Past

VitaFoods India 2025

Post author By Quality Smart Solutions
Post date January 14, 2025

Vitafoods India 2025 is a premier event for the food, beverage, and dietary supplement industries, bringing together professionals, innovators, and experts to explore the latest trends, solutions, and opportunities in the market.

GRAS Experts, a division of Quality Smart Solutions, will be attending, offering guidance on regulatory compliance for ingredients and finished products in key markets like Europe, the UK, and North America.

Blog

What Are Health Canada’s Rules for Probiotic Health Claims?

Post author By Quality Smart Solutions
Post date January 13, 2025

Navigating Health Canada’s rules for probiotic health claims can feel overwhelming, especially with the growing demand for these products. Businesses in the food and health product industries often struggle to understand the complexities of these regulations. However, ensuring compliance is essential for protecting your business and gaining consumer trust.

Probiotics are widely marketed as solutions for digestive health, immune support, and overall wellness. While the demand for these products continues to grow, making unsubstantiated health claims can result in serious regulatory consequences. Health Canada has established clear guidelines to ensure all claims are backed by science.

This article breaks down Health Canada’s rules for probiotic health claims, covering the key requirements and actionable tips to help your business stay compliant. Read on to learn how to navigate these regulations effectively.

What Does Health Canada Require for Probiotic Health Claims?

Health Canada has strict requirements for making health claims about probiotics or any microorganism. These claims must be based on robust scientific evidence demonstrating a clear and measurable benefit to human health.

Key Points to Know:

Scientific evidence is mandatory: Any health claims, such as “supports digestion” or “boosts immunity,” must be backed by peer-reviewed research or equivalent data. This ensures that consumers are not misled about the product’s benefits.
Proper use of the term “probiotic”: Simply labeling a product as “probiotic” suggests it offers health benefits. According to Health Canada, this term should only be used when the specific strain’s health benefits are supported by scientific evidence.
Clear labelling standards: Probiotic products must provide precise details on the label, including the strain’s name (e.g., Lactobacillus rhamnosus) and the quantity present in the product. This transparency helps consumers make informed decisions.

How to Ensure Your Probiotic Product Is Compliant

Navigating Health Canada’s requirements can be complex, but following these steps can streamline the process:

Invest in scientific research: Conduct or reference studies that validate your product’s health benefits. Collaborating with accredited research institutions can ensure your data meets regulatory standards.
Label products transparently: Use precise language to describe the strain, quantity, and specific health benefits of the probiotic. Avoid vague claims that could mislead consumers.
Consult regulatory experts: Partnering with regulatory compliance professionals can help you navigate Health Canada’s guidelines effectively and avoid costly mistakes.
Stay updated on regulations: Regulatory standards evolve. Regularly check Health Canada’s website or subscribe to updates to remain informed about changes that could affect your products.
Licence your product: Probiotic products are generally classified as Natural Health Products (NHPs) in Canada. This means you’ll need to licence your product and obtain a Natural Product Number (NPN) before selling.

Why Compliance Matters

Non-compliance with Health Canada’s rules for probiotic health claims can lead to serious consequences, including product recalls, fines, and damage to your brand’s reputation. By adhering to these guidelines, you not only avoid penalties but also build consumer trust and maintain your competitive edge.

For a detailed overview of permitted health claims and how they apply, visit Health Canada’s table of live microorganism health claims.

Need Help Navigating Probiotic Health Claims?

At Quality Smart Solutions, we specialize in helping businesses achieve compliance with regulatory requirements. Whether you’re launching a new product or updating your labeling, our experts are here to guide you every step of the way.

Tags food labeling, Health Canada, probiotics, Regulatory Compliance

News

Canada Simplifies Pet Food Imports from the US

Post author By Quality Smart Solutions
Post date January 12, 2025

Starting January 21, 2025, importing pet food products from the United States to Canada will become easier. Health Canada has announced significant updates to the documentation requirements for shipments of pet food, treats, and supplements. These changes aim to streamline processes and make compliance simpler for businesses.

Here, we’ll break down everything you need to know about these new rules, including deadlines, required documents, and actionable steps to stay compliant.

Key Changes to Pet Food Import Documentation

The updated regulations eliminate the need for the Importer’s Statement of Compliance. Instead, each shipment must now include:

A commercial invoice: This document should list all products and quantities in the shipment and must clearly reference the USDA zoosanitary export certificate number.

A zoosanitary export certificate: Issued by the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Services (APHIS), this certificate verifies compliance with health and safety standards.

These documents ensure transparency and facilitate smooth customs inspections.

Transition Period: Key Dates to Remember

Health Canada has implemented a three-month transition period from January 21 to April 21, 2025, to help businesses adjust to the new rules. During this period:

Shipments can still include the Importer’s Statement of Compliance.

By April 21, 2025, all commercial invoices must reference the USDA zoosanitary export certificate number.

After the transition period, failure to comply may result in shipment delays or penalties. Act now to ensure a seamless transition.

Why These Changes Are Important

The removal of the Importer’s Statement of Compliance is designed to:

Simplify documentation: Reduce administrative tasks and streamline shipping processes.

Improve traceability: Enhance the ability to track pet food products across borders.

Align with international standards: Support consistent regulatory practices for cross-border trade.

These updates save time and improve efficiency for businesses importing pet food products into Canada.

Steps to Ensure Compliance

Follow these steps to meet the updated requirements:

Update your processes: Ensure your commercial invoices include product details and the USDA certificate number.

Work with your suppliers: Verify that your US-based suppliers can provide the required zoosanitary export certificate.

Educate your team: Train staff on the new requirements to avoid errors and delays.

Stay informed: For questions or clarifications, contact Health Canada’s import team for animal products and by-products at APABPImport@inspection.gc.ca.

FAQs About the New Requirements

What happens if I don’t comply with the new documentation rules?
Non-compliance may lead to shipment delays, fines, or rejection at the border. Ensure you have the required documents for all shipments.

Can I still use the Importer’s Statement of Compliance during the transition period?Yes, but only until April 21, 2025. After this date, it will no longer be accepted.

How do I obtain a USDA zoosanitary export certificate?
Coordinate with your suppliers in the United States. They can secure this certificate from USDA APHIS.

How Quality Smart Solutions Can Help

Navigating regulatory updates can be challenging, but Quality Smart Solutions is here to assist. Our team of experts specializes in compliance and import regulations, ensuring your shipments meet all Canadian requirements.

Contact us today to learn how we can simplify your pet food import process and keep your business running smoothly. Stay compliant and confident as you adapt to these changes. Make 2025 your most efficient year yet for pet food imports.

Tags Canadian regulations, compliance updates, imports, pet food

News

Understanding the FDA’s Updated “Healthy” Nutrient Content Claim

Post author By Quality Smart Solutions
Post date January 11, 2025

The FDA has finalized its updated definition for the “Healthy” nutrient content claim, aiming to promote better transparency in food labeling and encourage healthier eating habits. This move is part of a broader initiative to improve public health by helping consumers make informed decisions.

If you’re a food manufacturer, distributor, or compliance expert, you need to stay ahead of these changes. Keep reading to understand what’s new and how it might affect your labeling practices.

Why the FDA’s Definition Matters

The FDA’s updated “Healthy” claim sets stricter criteria for food products that want to use this label. These criteria align with current nutritional science and dietary guidelines. Foods must now contain a meaningful amount of at least one of the food groups recommended by the Dietary Guidelines, such as fruits, vegetables, or whole grains. At the same time, limits on saturated fat, sodium, and added sugars must be met.

This update impacts manufacturers aiming to market their products as “healthy.” Non-compliance could lead to penalties or even product recalls, making it crucial to adapt your labeling strategy now.

Key Changes to the “Healthy” Label Requirements

Here are the primary changes you need to know:

Nutritional Standards: Products must meet specific criteria for beneficial nutrients and limits on unhealthy components.

Food Categories: The claim applies only to certain categories like fruits, vegetables, whole grains, and lean proteins. Processed foods face stricter scrutiny.

Added Sugars: A significant focus is on reducing added sugar levels in products labeled as “healthy.”

These updates not only redefine what qualifies as “healthy” but also challenge brands to innovate healthier recipes that meet these stricter guidelines.

How the New Definition Affects Your Compliance Strategy

For businesses, these updates mean reevaluating your product line to ensure compliance. Here’s how to get started:

1. Review Your Product Portfolio

Audit your products to identify those that currently use or plan to use the “Healthy” claim. Analyze their nutrient composition against the FDA’s updated standards.

2. Reformulate Recipes

If necessary, consider reformulating products to meet the criteria. This could involve reducing sodium, saturated fats, or added sugars and adding more whole grains or other beneficial nutrients.

3. Update Labeling Processes

Work closely with your compliance team to ensure your labeling practices align with the FDA’s new requirements. Incorrect labeling can lead to significant financial and reputational risks.

4. Educate Your Team

Ensure your marketing and regulatory teams understand the changes to avoid inadvertent non-compliance. Providing training on the new standards can mitigate future risks.

Benefits of Adapting to the New Guidelines

While the updates may pose initial challenges, they also present significant opportunities:

Building Consumer Trust: Accurate and transparent labeling strengthens your brand’s reputation.

Gaining a Competitive Edge: Products meeting these new standards could stand out as healthier choices, attracting more health-conscious consumers.

Contributing to Public Health: Aligning with the FDA’s goals helps promote better eating habits nationwide.

Supporting Your Compliance Efforts

Staying informed and proactive is essential. The FDA provides detailed resources and updates to guide businesses through these changes. Read the FDA’s official announcement here. For tailored compliance support, contact us at Quality Smart Solutions and book a free consultation today. Our team of experts can help you navigate these updates with ease.

Tags FDA compliance, food labeling, food regulations, nutrients

News

FDA Sets 2028 Compliance Date for Food Labels

Post author By Quality Smart Solutions
Post date January 10, 2025

The U.S. Food and Drug Administration (FDA) recently announced a uniform compliance date for food labeling regulations. This update establishes January 1, 2028, as the deadline for compliance with all final labeling rules published between January 1, 2025, and December 31, 2026.

By providing a consistent timeline, the FDA aims to reduce the economic and operational burden on food manufacturers and distributors, allowing them to adapt to changes in a more orderly fashion.

This decision highlights the FDA’s ongoing commitment to fostering transparency and consistency in the food labeling process. Understanding how this compliance date impacts your business is essential for staying ahead in an evolving regulatory landscape.

In this article, we will look at the FDA’s recent update and give you and your business clear steps to prepare effectively. Keep reading to learn more.

What Is the Uniform Compliance Date?

The FDA’s uniform compliance date ensures that all new food labeling regulations published within a specific timeframe adhere to a single implementation deadline. By setting January 1, 2028, as the compliance date, the FDA allows food manufacturers and distributors to:

Plan labeling updates systematically

Minimize economic disruptions from staggered regulatory deadlines

Optimize existing label inventories before transitioning to new requirements

The FDA also encourages businesses to adopt new labeling standards as early as possible to maintain compliance and consumer trust.

Why Does This Matter?

Uniform compliance dates provide significant benefits to the food industry, including:

1. Simplified planning

Rather than juggling multiple compliance deadlines, your team can focus on preparing for a single date. This simplifies project timelines, reduces stress, and ensures smoother transitions.

2. Cost savings

Updating labels is a costly endeavor. By consolidating compliance dates, you can maximize your use of existing label stock, reduce waste, and manage costs effectively.

3. Regulatory clarity

Having a uniform deadline avoids confusion and ensures everyone in the industry operates on the same timeline. This promotes consistency and fairness across the board.

Key Details of the FDA’s Update

Timeframe: The compliance date applies to labeling regulations published between January 1, 2025, and December 31, 2026.

Exceptions: Some regulations may have specific compliance dates if justified by unique circumstances. Always check final rule publications for details.

Implementation: All food products introduced into interstate commerce on or after January 1, 2028, must comply with the applicable labeling regulations.

For more information, visit the FDA’s official update.

How to Prepare for the 2028 Compliance Date

Evaluate current labels: Conduct an audit of your existing labels to identify areas that may require updates to align with forthcoming regulations.

Stay informed: Subscribe to regulatory updates from the FDA and consult trusted partners, like Quality Smart Solutions, for expert guidance.

Plan ahead: Begin developing a strategy to update your labels well before the 2028 deadline. This gives you ample time to address design, production, and inventory challenges.

Partner with experts: Navigating compliance can be complex. At Quality Smart Solutions, we provide tailored advice and support to help you meet FDA requirements with ease. Contact us today to learn more.

The FDA’s uniform compliance date for food labeling regulations offers a streamlined approach to regulatory adherence. By understanding the requirements and preparing early, you can avoid disruptions and stay ahead in the industry. Need help navigating FDA compliance? Reach out to Quality Smart Solutions for expert advice.

Tags FDA compliance, food labeling, industry updates, Regulations

News Press Releases

What Causes Foodborne Illness? Updates from the IFSAC Report

Post author By Quality Smart Solutions
Post date December 31, 2024

Credit: Rocky Mountain Laboratories,NIAID,NIH Color-enhanced scanning electron micrograph showing Salmonella typhimurium (red) invading cultured human cells.

The Interagency Food Safety Analytics Collaboration (IFSAC), a joint initiative of the FDA, CDC, and USDA-FSIS, has recently released its 2022 Annual Report on Foodborne Illness Source Attribution Estimates. This comprehensive report sheds light on the primary sources of foodborne illnesses caused by Salmonella, Escherichia coli O157, and Listeria monocytogenes, offering critical insights for food safety stakeholders.

Foodborne Pathogens and Their Sources

The 2022 report highlights the leading food categories associated with these pathogens, providing actionable data to reduce foodborne illness outbreaks:

Salmonella

Top Sources: Chicken, turkey, and seeded vegetables.
Impact: One of the most prevalent causes of foodborne illnesses and hospitalizations, causing diarrhea, fever, and abdominal cramps. Can be life-threatening in young children, the elderly, and those with weakened immune systems.
Key Considerations: Salmonella is often present in the intestines of animals, making cross-contamination a significant concern during food processing.
By The Numbers/Annual Statistics: Salmonella causes an estimated 1.35 million illnesses, 26,500 hospitalizations, and 420 deaths in the United States every year.
Prevention Strategies: Consumers should cook poultry thoroughly to 165°F (74°C), wash hands and surfaces after handling raw poultry, and thoroughly wash seeded vegetables. The industry should implement strict hygiene practices during processing and use appropriate antimicrobial treatments.

E. coli O157

Top Sources: Leafy greens and beef.
Impact: Causes severe diarrhea (often bloody), abdominal cramps, and vomiting. Can lead to kidney failure in young children.
Key Considerations: Can survive in acidic environments and at low temperatures, making it challenging to eliminate.
Prevention Strategies: Consumers should thoroughly wash leafy greens, cook beef to an internal temperature of 160°F (71°C), and avoid cross-contamination between raw meat and other foods. The industry should implement stringent hygiene practices during cultivation and processing of produce and use effective sanitation methods in beef processing plants.
By The Numbers/Annual Statistics: E. coli O157 causes an estimated 63,153 illnesses, 2,138 hospitalizations, and 20 deaths in the United States each year.

Listeria monocytogenes

Top Sources: Dairy products (especially soft cheeses), deli meats, and fruits.
Impact: Causes fever, muscle aches, and sometimes gastrointestinal symptoms. Can lead to severe complications like meningitis and sepsis, especially in high-risk groups.
Key Considerations: Listeria is unique because it can grow at refrigerator temperatures, making it a concern in ready-to-eat foods with longer shelf lives.
Prevention Strategies: Consumers, especially high-risk individuals, should avoid soft cheeses, deli meats, and unpasteurized dairy products and thoroughly wash fruits before consumption. The industry should maintain strict temperature control during processing and storage and implement environmental monitoring programs to detect Listeria in processing facilities.
By The Numbers/Annual Statistics: Listeria causes an estimated 1,600 illnesses, 1,500 hospitalizations, and 260 deaths in the United States annually.

How This Report Helps Improve Food Safety

The IFSAC report is a cornerstone resource for food industry professionals, public health officials, and policymakers. Its data enables:

Enhanced Risk Management: Identifying high-risk foods to prioritize safety measures.
Strengthened Compliance: Aligning practices with updated FDA and USDA regulations.
Informed Decision-Making: Supporting data-driven strategies to mitigate contamination risks.

Empowering Food Safety Stakeholders

The report’s actionable insights regarding foodborne illness can be applied across the food supply chain:

Manufacturers: Implement rigorous testing and preventive controls for high-risk products.
Retailers: Educate staff and consumers on safe handling practices.
Regulators: Focus inspections and resources on the most susceptible food categories.

A Call to Action for Safer Food Practices

IFSAC’s 2022 Annual Report emphasizes the importance of collaboration and proactive measures in combating foodborne illness. By addressing the identified sources, the food industry can play a pivotal role in reducing outbreaks and protecting public health.

To explore the full report and its findings, visit the FDA website.

Tags Food Safety, foodborne illness, IFSAC report

Blog News

MoCRA GMP Delayed Until October 2025: What You Need to Know

Post author By Quality Smart Solutions
Post date December 18, 2024

The U.S. Food and Drug Administration (FDA) has postponed the implementation of the Modernization of Cosmetics Regulation Act (MoCRA) Good Manufacturing Practices (GMPs) until October 2025.

Originally scheduled for December 29, 2024, this delay offers businesses additional time to prepare for compliance. Here’s what this means for companies navigating MoCRA compliance and how to leverage the extension to stay ahead.

MoCRA, signed into law in December 2022, marked a historic shift in cosmetics regulation by the FDA. Among its key provisions is the requirement for companies to adhere to Good Manufacturing Practices (GMP), ensuring product safety and quality throughout the manufacturing process. The aim is to modernize the cosmetics industry, offering enhanced consumer protections while aligning with global standards.

Why the delay and how it impacts cosmetics companies?

The FDA’s decision to delay MoCRA GMP until October 2025 stems from the need for more detailed regulatory guidance and industry feedback. While the agency works on refining these rules, businesses must still adhere to other MoCRA mandates, such as registration, product listing, and fragrance allergen labeling, which take effect sooner. Key deadlines to watch include the following:

Fragrance allergen labeling: Targeted for January 2026.
Registration and listing requirements: Enforcement begins mid-2024.

The postponement provides a critical window for companies to:

Assess current practices: Conduct internal audits to evaluate compliance gaps in manufacturing processes.
Develop compliance strategies: Create or update Standard Operating Procedures (SOPs) aligned with anticipated MoCRA GMP requirements.
Invest in training: Educate teams on MoCRA compliance to ensure readiness when enforcement begins.

Steps to Take Now

While the delay grants more time, proactive measures can set your company up for success:

1. Register and List Products Early

Stay ahead by completing your MoCRA registration and product listings before the mid-2024 deadline. These foundational steps are critical to maintaining compliance.

2. Strengthen Documentation

Ensure meticulous record-keeping of manufacturing practices, ingredient sourcing, and testing protocols. These records will be vital once GMP enforcement begins.

3. Monitor FDA Updates

Keep an eye on the FDA’s announcements for the finalized GMP guidelines and adjust your strategies accordingly. Complying with MoCRA GMP standards ahead of schedule not only ensures regulatory readiness but also enhances brand trust and reputation. Companies that prioritize safety and transparency will likely gain a competitive edge in an increasingly regulated market.

Don’t Delay. Prepare Today

The FDA’s extension of the MoCRA GMP deadline provides an invaluable opportunity to get your processes in order. Use this time to ensure your business not only meets regulatory standards but also positions itself as a leader in product safety and quality.

If you’re unsure where to start, Quality Smart Solutions is here to help. Our team of compliance experts specializes in guiding businesses through MoCRA compliance, from registration to certification. Contact us today to ensure your business is prepared to thrive in this new era of cosmetics regulation.

Tags MoCRA compliance, MoCRA cosmetics, MoCRA deadlines, MoCRA GMP, MoCRA product listings

Blog News

FDA Updates Guidance on Genome-Edited Foods

Post author By Quality Smart Solutions
Post date December 16, 2024

The U.S. Food and Drug Administration (FDA) has published an update to its guidance for voluntary premarket engagement regarding foods derived from genome-edited plants. This initiative highlights the agency’s commitment to ensuring food safety while fostering innovation in agricultural biotechnology.

The FDA’s update includes the release of an inventory of voluntary premarket meetings held with developers of genome-edited plant-based foods. These meetings are intended to provide a platform for early engagement, allowing developers to address potential safety and regulatory concerns before marketing their products.

This inventory serves as a public resource, offering transparency into the types of products entering the market and the FDA’s role in ensuring their compliance with food safety standards.

A Distinction in Premarket Processes

The FDA’s guidance outlines two distinct premarket processes:

Voluntary Premarket Engagement: Designed for genome-edited foods with lower risk characteristics, this process allows developers to discuss their products and clarify regulatory expectations.
Voluntary Premarket Consultation: Recommended for products that may pose greater safety or regulatory challenges, this pathway involves a more comprehensive review process.

As you can see, both processes are voluntary but provide developers with valuable insights to streamline their product’s market entry.

A Growing Inventory

The FDA’s inventory of voluntary premarket meetings is expected to expand as more developers engage with the agency. By maintaining this resource, the FDA aims to encourage transparency and provide a clearer understanding of the safety evaluations associated with genome-edited foods.

Implications for Developers

This update underscores the importance of proactive collaboration between food developers and the FDA. By participating in voluntary premarket engagement, developers can:

Gain early feedback on potential safety issues.

Ensure compliance with regulatory requirements.

Expedite the commercialization of genome-edited products.

Foods derived from genome-edited plants must meet Generally Recognized As Safe (GRAS) standards. GRAS status is granted when the FDA determines that a food is as safe as conventional foods. It involves a rigorous review of safety data, including toxicology and allergen testing, to ensure consumer health is protected. Because these foods involve genetic modifications, proving their safety is essential before they reach consumers.

This process might seem overwhelming, but you don’t have to go it alone. Experts like Quality Smart Solutions and GRAS Experts specialize in helping developers navigate GRAS requirements. Their guidance can save you time, ensure compliance, and streamline your journey to market.

The Broader Context

Genome editing has become a cornerstone of agricultural innovation, offering opportunities to enhance crop yields, improve nutritional content, and reduce environmental impacts. As these technologies evolve, the FDA’s guidance serves as a critical framework for balancing innovation with safety.

The agency reaffirmed that all foods derived from genome-edited plants must meet the same rigorous safety standards as other foods, emphasizing its commitment to public health.

Accessing the Guidance

Developers and stakeholders can review the full guidance and inventory on the FDA’s website. The agency encourages developers to consider these resources as part of their product development and regulatory planning.

For more information, visit the FDA’s official update.

Tags FDA guidance, Food Safety, genome-edited foods, premarket engagement, Regulatory Compliance

Blog

VHP Representative vs. Importer of Record: Key Differences

Post author By Quality Smart Solutions
Post date December 16, 2024

If you’re planning to bring veterinary health products (VHPs) into Canada, you’ve probably come across the terms VHP Canadian representative and VHP Importer of Record. Sounds technical, right? But don’t worry, it’s not as complicated as it seems! These roles may sound similar, but they have distinct responsibilities that are essential to your success in the Canadian market.

Understanding the differences between these two roles can save you a lot of time, money, and stress. To help you navigate these requirements with confidence, we’ve broken it all down for you. Keep reading to discover what these roles are all about and why you need both for smooth operations.

What is a VHP Canadian Representative?

A VHP Canadian representative is your trusted partner when it comes to meeting Canadian regulations. If you’re a foreign manufacturer selling VHPs in Canada, this role isn’t optional, it’s required. Essentially, they’re your regulatory guide, helping you navigate the rules and acting as your main contact with Health Canada. Their key responsibilities include:

Liaising with Health Canada regarding product registration.
Assisting in maintaining compliance with Canadian VHP regulations.
Addressing any queries or concerns related to product safety.

With a knowledgeable Canadian representative on your side, you’ll save time and avoid potential issues. Plus, they make it easier for you to focus on other parts of your business.

What is a VHP Importer of Record?

In contrast, the VHP Importer of Record is responsible for ensuring that products entering Canada meet all importation requirements. This individual or entity facilitates customs clearance and ensures compliance with Canadian import regulations. Responsibilities include:

Handling customs documentation and declarations.
Ensuring that imported VHPs meet Canadian standards.
Managing duties, taxes, and other import-related fees.

In other words, they’re the ones who make sure your products get from point A to point B without any hiccups.

How Do These Roles Work Together?

Although the VHP Canadian representative and VHP Importer of Record have separate responsibilities, they complement each other perfectly. A VHP Canadian representative acts as the liaison between the foreign manufacturer and Health Canada, ensuring product compliance and addressing regulatory concerns.

On the other hand, a VHP Importer of Record is responsible for managing the logistics and legalities of bringing VHPs into Canada, including customs clearance and meeting importation standards.

By working together, these roles ensure that both regulatory and logistical aspects are covered, giving you peace of mind and allowing you to focus on growing your business.

In essence, for a smooth and compliant entry into the Canadian market, both roles are essential, and without them, your business risks operational setbacks.

Partner with Quality Smart Solutions

At Quality Smart Solutions, we specialize in supporting VHP manufacturers and importers navigate the complexities of the Canadian regulatory landscape. By partnering with us, you can focus on growing your business while we handle the regulatory details.

Ready to simplify your Canadian operations? Explore our VHP services for Canada or contact us today to get started!

Tags Importer of Record, Veterinary Health Products, VHP, VHP Representative

Blog News

Health Canada Infant Formula Policy Transition

Post author By Quality Smart Solutions
Post date December 12, 2024

Are you prepared for changes to Health Canada’s regulations on infant formulas and dietary products? The Interim Policy on Importation and Sale ends on December 31, 2024. To ensure compliance and long-term availability, you need to align your products with the Food and Drugs Regulations (FDR). Let’s explore what this means and how you can adapt.

What Is the Interim Policy?

Health Canada introduced the interim policy in 2022 to stabilize supply during shortages. It allowed temporary importation of products that didn’t fully comply with regulations.

Now, Health Canada aims to replace this temporary measure. By launching a transition strategy, it ensures all products meet Canadian standards for the future.

The policy will expire on December 31, 2024, for products that don’t participate in the transition strategy. After this date, Health Canada will remove non-compliant products from Appendix A.

Products imported before the deadline can still be sold. However, this is only possible while supplies last and within their shelf-life.

How to Transition Your Products

If your product appears in Appendix A, follow these steps to stay compliant:

Engage with Health Canada: Work closely with Health Canada to meet FDR requirements.
Monitor updates: Regularly check Appendix A for changes as products are evaluated.
Secure approvals: Once compliant, your product will move to Health Canada’s online list of approved items.

Don’t wait until it’s too late. Start the transition process now to ensure uninterrupted market access. Compliant products will benefit from long-term availability in Canada. For infant formulas, this means:

Removal from Appendix A of the interim policy.
Addition to Health Canada’s official list of reviewed products, available in stores and pharmacies.

Take Action and Avoid Disruption

Ensure your products meet Health Canada’s requirements before the December 31, 2024, deadline. Proactively transitioning your products will prevent disruptions and maintain their market availability. Check Health Canada’s website to stay updated on regulatory changes and find helpful resources.

Quality Smart Solutions specializes in guiding businesses through Health Canada’s compliance requirements. Our expert team can assist with product evaluations, approvals, and seamless transitions to ensure your products remain available in the Canadian market. Contact us today to start your compliance journey and secure your market access for 2025 and beyond.

Tags Health Canada, infant formula

Blog

How to Sell NHPs on Amazon Canada: A Complete Guide

Post author By Quality Smart Solutions
Post date December 10, 2024

Selling natural health products (NHPs) on Amazon Canada is a lucrative opportunity to expand your business and reach millions of potential customers. However, navigating the process requires understanding and adhering to Canadian regulations, as well as Amazon’s specific policies for NHPs.

From securing the necessary approvals to optimizing your product listings and driving sales, there are key steps to ensure your success. In this guide, we’ll walk you through everything you need to know to get your NHP listed and start selling successfully. Keep reading to unlock actionable tips and insights.

Understanding NHP Regulations in Canada

Before you can sell your NHP on Amazon Canada, it must meet Health Canada’s regulatory requirements. Every NHP sold in Canada requires a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) to confirm it’s safe, effective, and properly labeled. Obtaining an NPN might seem complex, but by following these steps, you can navigate the process with confidence:

Submit an application: Use Health Canada’s Natural Health Products Online System (NHP Online) to apply for your NPN.
Provide evidence: Include supporting data, such as ingredient safety, dosage, and proposed health claims.
Approval process: Once approved, you’ll receive your NPN, allowing you to legally sell your product in Canada as long as your label accurately reflects the product licence. The label must be in both French and English for sale in Canada.

Setting Up Your Amazon Canada Seller Account

After obtaining your NPN, it’s time to create your Amazon Canada seller account. Choose between Individual or Professional plans, depending on your sales volume. To streamline your process, consider these key points:

Category approval: Apply for approval to sell in the NHP category. Amazon requires documentation, such as your NPN and product labels.
UPC/EAN codes: Ensure your product has valid barcodes for Amazon listings.
Shipping and fulfillment: Decide whether to handle logistics yourself or use Fulfillment by Amazon (FBA) for faster delivery and Prime eligibility. Please note that if you are storing products manufactured outside of Canada prior to reaching distribution channels, these sites may require approval through a valid iNHP import site licence. Imported NHPs must be reviewed and released for sale by an active site licence holder. This process will take into consideration the certification requirements of any third party responsible for the licensable activities of your products, such as manufacturing, labelling, packaging, and storage.

Optimize Your NHP Listings

Your Amazon product listing is the cornerstone of your online sales strategy. It’s not just about informing potential customers but also about convincing them to buy. Start by incorporating relevant keywords in your product title and description. These could include terms like “Natural Health Products” and specific benefits of your product.

It’s also essential to emphasize your product’s unique features, such as organic ingredients or eco-friendly packaging. Pair these descriptions with high-quality images that present your product from various angles. For added impact, ensure the images look professional and include alt text, such as: “Natural health product approved by Health Canada.”

Staying Compliant with Amazon and Health Canada

Maintaining compliance is crucial to avoid penalties or account suspension. Here’s what to watch for:

Label accuracy: Ensure all labels meet Health Canada’s standards, including proper ingredient lists and claims.
Inventory management: Monitor stock levels and expiration dates to prevent customer complaints, alongside adherence to traceability requirements in the event of a recall.
Customer feedback: Respond promptly to reviews and questions to build trust and improve your ratings.

Driving Sales With Marketing

After setting up your product listing, marketing becomes the key to driving traffic and boosting sales. Consider leveraging Amazon Ads to target customers searching for products like yours. Sponsored Product Ads can place your listing at the top of search results, giving you greater visibility.

Another effective strategy is to optimize your product descriptions regularly by integrating trending keywords. Beyond Amazon, social media campaigns can further amplify your reach. Platforms like Instagram and Facebook are excellent for showcasing your product and connecting with potential buyers.

How We Can Help

Selling NHPs on Amazon Canada doesn’t have to be overwhelming. With the right preparation and strategies, you can turn this opportunity into a profitable venture. At Quality Smart Solutions, we specialize in helping businesses like yours navigate Health Canada regulations, optimize Amazon listings, and implement effective marketing campaigns. Contact us today or explore our NHP compliance services to get started on your journey to success.

Tags Health Canada NPN, Natural Health Products, NHP compliance, NHPs on Amazon Canada